Director, Analytical Development

ModernaTX

Job Location:

Norwood, MN - USA

Monthly Salary: $ 167000 - 300700

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is strengthening its presence in Norwood Massachusetts a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide.

In this role you will lead bioassay development strategy for late-stage programs within the Potency Assurance function ensuring cell-based assays are fit-for-purpose for clinical development validation and commercialization.
As a Director you will operate at the intersection of product biology analytical development and quality translating complex mechanisms of action into robust scalable and regulatory-aligned bioassays that enable global filings and commercial supply.
Working 100% onsite in Norwood as a strategic leader without initial direct reports you will influence across functions while leveraging advanced digital tools and Generative AI to enhance assay strategy data interpretation and lifecycle management.

Heres What Youll Do:

Define and drive potency assay strategy for late-stage programs aligning with product mechanism of action CQA frameworks and regulatory expectations
Lead development qualification validation and lifecycle management strategies for cell-based bioassays supporting clinical and commercial products
Ensure bioassays are mechanistically relevant connecting product biology to assay design performance and control strategies
Provide strategic leadership for CMC bioassay development supporting IND/BLA submissions and commercial readiness
Interpret and apply global regulatory guidelines (e.g. ICH FDA EMA) to assay development and lifecycle activities
Support regulatory filings health authority questions and interactions related to bioassays
Partner cross-functionally with Quality QC and Analytical Sciences & Technology (AS&T) to enable method transfer validation and commercialization
Drive resolution of bioassay-related challenges including investigations deviations and comparability assessments
Lead through influence across cross-functional teams setting priorities aligned with program and organizational goals
Oversee potency deliverables across programs translating technical challenges into risks and mitigation strategies

The key Moderna Mindsets youll need to succeed in the role:

We behave like owners. The solutions were building go beyond any job description.

We act with dynamic range driving strategy and execution at the same time at every step.

Heres What Youll Need (Basic Qualifications)

Ph.D. (preferred) with 10 years of relevant industry experience MS with 12 years of relevant industry experience or BS with 15 years of relevant industry experience in Biochemistry Molecular Biology Cell Biology Immunology Biological Engineering or related field
Strong experience in bioassay development within a CMC environment particularly for late-stage (Phase 2/3 or commercial) programs
This position is site-based requiring you to be at Modernas site full-time. This position is not eligible for remote work.

Heres What Youll Bring to the Table (Preferred Qualifications)

Preferred experience with bioassay development for RNA and/or LNP-related products
Demonstrated expertise in cell-based potency assays for vaccine rare disease and/or oncology applications including development qualification validation and lifecycle management
Deep understanding of regulatory expectations and guidelines (e.g. ICH FDA EMA) for bioassays supporting clinical and commercial products
Experience supporting regulatory submissions and health authority interactions
Proven ability to drive method transfer validation and commercialization readiness
Strong understanding of analytical control strategies comparability and assay lifecycle management
Demonstrated leadership experience managing teams and influencing cross-functional stakeholders
Excellent communication and strategic thinking skills with the ability to connect scientific decisions to CMC and business impact

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

Best-in-class healthcare coverage plus voluntary benefit programs to support your unique needs
A holistic approach to well-being with access to fitness mindfulness and mental health support
Family planning benefits including fertility adoption and surrogacy support
Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

The salary range for this role is $167000.00 - $300700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individuals position within the salary range will be based on several factors including but not limited to specific competencies relevant education qualifications certifications experience skills performance and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus other incentive compensation or equity award subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Our Working Model

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .

Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-TR2

Required Experience:

Director

The Role:Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.Moderna is strengthening its presence in Norwood Massachusetts a cornerstone of our manufacturing and opera...